Judge Denies Defendants’ Preemption Motions In Valsartan MDL

On December 17, 2020, U.S. District Judge Robert B. Kugler ruled that the plaintiffs’ claims are not preempted in the Valsartan contamination multidistrict litigation (MDL). This ruling makes sure that claims against manufacturers, wholesalers, and pharmacies will continue in the MDL over their alleged failure to keep contamination out of Valsartan. 

Specifically, Judge Kugler noted that the defendants failed to take into account the U.S. Supreme Court precedent that the states’ policing powers can supersede federal law if that was the clear intent of Congress.

What is the Preemption Argument from Valsartan Manufacturers?

Valsartan manufacturers have asserted that they were prohibited by federal regulations determined by the U.S. Food and Drug Administration (FDA) from warning consumers about the contamination within the drug. They claimed that they could not alter their manufacturing process without FDA approval in addition to the Food, Drug and Cosmetic Act and the Drug Supply Chain Security Act (DSCSA)’s requirements which they claim can only be enforced by the government. 

Valsartan manufacturers, wholesalers, and pharmacies such as Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., AmerisourceBergen, Cardinal Health Inc., CVS and Walgreens all made the preemption argument.

Background on Preemption Arguments

Preemption arguments stem from the Supremacy Clause of the U.S. Constitution. It states that when state and federal law conflict, the federal law preempts (overpowers) state law. In the case of prescription drugs, Congress has allowed the U.S. Food and Drug Administration (FDA) to set the minimum national standards; therefore, their powers are viewed as federal law. The FDA has the primary responsibility to review the safety, efficacy, and labeling of medical products. 

Regarding drug manufacturers, states usually cannot penalize drug manufacturers for not including a warning that the FDA has already deemed to be unnecessary as long as the manufacturer follows all of the FDA’s other guidelines. Therefore, manufacturers cannot be held accountable to differing laws and regulations that may be enacted in 50 different states. 

The federal drug labeling preemption argument is based on the requirement that the brand-name drug has been tested and vetted by the FDA prior to entering the market. Since generic drugs are required by federal law to be a bioidentical drug, the argument is that different warnings are unnecessary and that generic manufacturers therefore cannot be held responsible for failing to provide additional or different warnings regarding their medication.

Injuries from Contaminated Valsartan

Valsartan’s contamination with the probable human carcinogen N-nitrosodimethylamine (NDMA) can create an increased risk for the following cancers: 

  • Bladder Cancer
  • Blood Cancer 
  • Breast Cancer
  • Colorectal / Intestinal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer 
  • Pancreatic Cancer
  • Pharyngeal Cancer
  • Prostate Cancer
  • Uterine Cancers 

What Was Judge Kugler’s Reasoning Behind The Ruling?

Judge Kugler explained that Congress’ intent in passing the DSCSA was to protect consumers from exposure to drugs that may be “counterfeit, stolen, contaminated or otherwise harmful” by creating a national system for product tracing. He determined that the DSCSA does not preempt state requirements pertaining to aspects of distributing drugs: “Although the preemption clause seeks to eliminate inconsistent state regulations related to tracing of pharmaceuticals, Congress did not enact the DSCSA in an effort to displace all state law regarding defective pharmaceutical drugs. Under the defendants’ view of the Act, Congress would have barred most, if not all, relief for persons injured by defective pharmaceuticals.”  

Judge Kugler added that there is no danger of inconsistent rulings since the FDA has already researched the cause of the contamination sufficiently to develop an understanding about the chemical processes involved in creating it.

How Does It Impact the Valsartan MDL?

Valsartan MDL Judge Kugler’s rejection of the defendants’ dismissal motion based on the preemption argument is a boost for the plaintiffs in the Valsartan MDL. The personal injury, economic loss, and medical monitoring lawsuits that are at stake in the MDL may continue to move forward due to this ruling. 

GoldenbergLaw Can Help

If you or a loved one has been diagnosed with cancer after taking the blood pressure medication Valsartan, contact the Dangerous Drug Attorneys at GoldenbergLaw for a free consultation. With thirty-four years of experience, we have the knowledge, experience, and compassion to give you the Gold standard of advocacy that you deserve. Contact us today to discuss a free Valsartan lawsuit consultation and leave the sleepless nights to us!

NP Thyroid Medication Recall

NP Thyroid May 2020 Recall

On May 22, 2020, Acella Pharmaceuticals, LLC issued a voluntary national recall of specific lots of their NP Thyroid (Thyroid Tablets, USP) medication. NP Thyroid is used to treat hypothyroidism using a combination of hormones—levothyroxine and liothyronine. In total, 13 lots of 30mg, 60mg, and 90mg of the drug were recalled due to super potency found within the medication. The lots were found to contain up to 115% of the labeled amount of the hormone liothyronine (T3).

Patients who are being treated for hypothyroidism (underactive thyroid) with the medication and consume the lots of super potent medication may experience signs and symptoms of hyperthyroidism (overactive thyroid).

Symptoms of Hyperthyroidism (Overactive Thyroid)

  • Weight loss
  • Heat intolerance
  • Fatigue
  • Muscle weakness
  • Hypertension
  • Chest pain
  • Rapid heart rate
  • Heart rhythm disturbances

Pregnant women who consume a super potent lot may experience negative maternal and fetal outcomes, which can include miscarriage and/or impairment to fetal development.

At the time of the recall, Acella Pharmaceuticals had received two reports of adverse events caused by the super potent lots of the medication.

FDA Investigates Acella Pharmaceuticals for Lax Controls

The FDA issued a warning letter to Acella Pharmaceuticals in August 2020 after quality control issues were discovered in their manufacturing process that ultimately led to the recall of NP Thyroid medications in May 2020.

The FDA investigated the company between December 2019 and January 2020 and determined that Acella failed to use appropriate safety evaluations for active pharmaceutical ingredients (API) used in the NP Thyroid drug. Some of these API’s had been provided to Acella by third party contract manufacturers. However, the FDA regards contractors as an extension of manufacturer and ultimately the manufacturer is responsible for the safety of the ingredients added to its products. The FDA’s investigation found 13 lots of NP Thyroid that exceeded the specified strength—these lots were deemed to be super potent and led to the May 2020 recall.

In its warning letter, agency determined that Acella did not have proper safety protocols in place to evaluate the quality of ingredients provided by its third party contractors, which led to the super potent lots of NP Thyroid being improperly distributed.

The investigation also uncovered that Acella had failed to pursue a long-term stability study for lots of NP Thyroid produced by its CMO and a new API supplier in May 2019. This means that almost a year after the drugs were manufactured, validation batches of the drug had not been studied for long-term potency. This creates concerns for the shelf life of the medication. The FDA said that due to the “narrow therapeutic range” of NP Thyroid, out-of-spec dosing could pose serious side effects for patients.

NP Thyroid September 2020 Recall

On September 17, 2020, Acella Pharmaceuticals issued another voluntary nationwide recall of two lots of NP Thyroid (Thyroid Tablets, USB), this time due to sub potency. Testing revealed that the recalled lots had as low as 87% of the labeled amount of the levothyroxine (T4) hormone needed as part of the combination levothyroxine (T4) and liothyronine (T3) medication.

Patients who are being treated for hypothyroidism (underactive thyroid) and receive a sub potent lot of the medication may experience symptoms of hypothyroidism.

Symptoms of Hypothyroidism (Underactive Thyroid)

  • Fatigue
  • Increased sensitivity to cold
  • Constipation
  • Dry skin
  • Puffy face
  • Hair loss
  • Slow heart rate
  • Depression
  • Swelling of the thyroid gland
  • Unexplained weight gain
  • Difficulty losing weight

So far, Acella Pharmaceuticals has received four reports of adverse events likely related to the recall.

What Does the Thyroid Do?

The thyroid is an endocrine gland located at the base of the neck and produces two hormones—levothyroxine (T4) and liothyronine (T3). The thyroid works to regulate the body’s temperature, and help control other process such as hair and nail growth, the speed at which food is metabolized, and heart rate.

Hypothyroidism vs. Hyperthyroidism

Hypothyroidism is a condition that occurs when the thyroid is underactive. Basically, the thyroid gland does not produce enough of the T3 and T4 hormones. If a person does not have enough of these hormones, bodily processes begin to slow down. The body produces less energy and metabolism becomes slower. The most common cause of hypothyroidism is Hashimoto’s thyroiditis which is the inflammation of the thyroid gland. Other common causes include the surgical removal of the thyroid and radiation treatment.

Hyperthyroidism occurs when the thyroid is overactive. Therefore, the thyroid produces too much of the T3 and T4 hormones. This can result in the body’s metabolism increasing and can cause unintentional weight loss and a rapid or irregular heartbeat.

How GoldenbergLaw Can Help

The Minnesota Defective Drug Attorneys at GoldenbergLaw have been helping clients receive justice for over thirty years. Contact us today for a free thyroid medication recall lawsuit consultation and leave the sleepless nights to us!

The Dangers of Medication Errors

What are Medication Errors?

Medication errors can create countless devastating impacts that can be long-term, serious, debilitating, and may even cause death. There are more than 100,000 medication errors reported to the U.S. Food and Drug Administration every year and, sadly, most of these errors are preventable.

Proper oversight may be overlooked on multiple levels of patient care which can result in tragic drug-induced injuries. In hospitals, dosing and drug administration should be quality checked by multiple professionals to ensure that patients are not at risk for the potentially fatal complications caused by medication errors.

Specific types of medication errors include:

  • Prescription errors
  • Medication omission
  • Unauthorized drug admission
  • Improper dosing
  • Incorrect dose preparation
  • Drug administration into the wrong part of the body

Medication errors can cause serious injuries to the patient. One such injury is called neurotoxicity. Neurotoxicity occurs when a patient is exposed to natural or manmade toxic chemicals known as neurotoxicants that alter the normal activities of the nervous system. This can lead to key cells known as neurons being killed. These neurons are vital for the transmission of process signals in the brain and other components of the nervous system. This neurotoxicity can be caused by:

  • The toxic nature of the drug’s pharmacology/chemistry
  • The relative dispersion of the agent within the brain
  • Cell death and damage to important central nervous system structures

What Can Happen If I Suffer from a Medication Error?

Serious complications from medication errors such as neurotoxicity can result in problems including:

  • Cognition
  • Memory
  • Vision
  • Hearing problems

Depending on the error’s severity, the mistake can go unnoticed or contribute to injuries that can even result in the patient’s death. Factors that impact how serious the toxic side effects can be include:

  • Whether the drug dosing is incorrect
  • If the drug was administered properly
  • If too much of the drug was administered (overdose)
  • If the patient has a condition which the drug contraindicated (the drug was not supposed to be used in patients with that condition)

What are Examples of Medication Error Cases?

Pharmacologists have analyzed the significant and debilitating effects of a generally safe class of drugs—contrast agents—that are used for imaging and radiology procedures to illustrate the dangers of medication errors.

In these cases, the patients experienced mediation errors in which they were incorrectly administered contrast agents (used to improve the pictures taken into the body produced by x-rays, computed tomography (CT), magnetic resonance (MR) imaging, and ultrasound in their myelography imaging procedures. Myelography is a type of radiographic (x-ray or CT scan) imaging examination that doctors use to see inside the spinal cord to look for injury, cysts, tumors, and other abnormalities. The doctor inserts a contrast agent which acts like a dye into the patient’s spinal canal to visualize the images of the spinal cord. The contrast agents make the structures and tissues appear more defined compared to the surrounding tissue. Unfortunately, the majority of patients that receive an overdose or inadvertent (accidental administration into the body/spinal cord) injections of contrast agents die from the complications.

The following case studies were analyzed by James T. O’Donnell PharmaD and James J. O’Donnell PhD and were published in “Rxisk: Making Medicines Safer for All of Us.”

Case 1

In the first case, a middle-aged woman was undergoing a myelogram procedure and given an intrathecal injection which contained an overdose of ISOVUE-M which is a type of contrast agent. The patient was given two to three times the recommended dose of the contrast agent and two times the recommended maximum dose for the procedure. After the procedure, the patient developed altered cognitive ability, memory loss, and seizure activities. A brain scan revealed that the ISOVUE-M contrast agent was in spaces surrounding the brain. Images of the cerebral spinal fluid show that concentrations of the contrast agent were more than 200 times higher than normal. The excessive levels of the contrast agents were exposed to the patient’s brain tissue for an extended period of time and resulted in significant complications such as cognitive deficits, seizures, impairments in memory function, and significant hearing loss.

This occurred despite the fact that the drug manufacturer specifically warned against entry of the drug into the brain and stated that the entry of a large or concentrated amount of contrast agent increases the risk of neurotoxicity. The complications the patient experienced matched those that were listed by the manufacturer for the impacts on the nervous system if a medication error occurs. The drug’s access to the brain caused significant and irreversible contrast neurotoxicity which resulted in the death of brain cells.

Case 2

In the second case, a middle-aged man was scheduled for a myelogram procedure as part of a vertigo workup (a condition where one experiences the sudden sensation that there head is spinning). During the procedure, the patient was inadvertently administered an intrathecal overdose of Conroy, which is a contrast agent that is not to be used in this type of procedure. Following the injection, the patient experienced signs of contrast-induced neurotoxicity, including lower limb disturbances, seizures, cognitive dysfunction, and memory loss. The patient also had burning and prickling sensations, tingling, and spasms. After treatment for the medication error and subsequent discharge, the patient continued to experience persistent cognitive impairment, including inability to concentrate and multitask, and dull tension-like headaches. The patient continues to suffer from neuromuscular impairments such as overactive or overresponsive reflexes, dizziness, unsteadiness, generalized weakness and muscle spasms.

Once again, the manufacturer had warned against the use of intrathecal administration and stated that serious neurological adverse events may occur—including death. The accidental administration of the highly toxic and contraindicated contrast agent resulted in the direct entry of the drug into the brain causing significant and irreversible contrast neurotoxicity—the killing of brain cells.

Illustrating the Dangers of Medication Errors

Both medication error cases resulted in significant neurotoxicity causing permanent damage to brain structures and subsequent clinical manifestations. The toxic contrast agents were given access to the brain and then disrupted the normal brain signaling, causing brain cell death.

GoldenbergLaw Can Help

With over thirty years of experience litigating challenging medical malpractice, the Minnesota Medical Malpractice attorneys at GoldenbergLaw will fight to get you the justice that you deserve. Leave the sleepless nights to us by contacting us today!